Mycozol Capsule 150 mg (Fluconazole)

Adult dose

The route of administration should be determined according to the patient's clinical condition. Because oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Usually administer 400 mg of this medicine once on the first day, followed by 200 mg once daily from the next day; the dose may be increased to 400 mg once daily depending on the patient's response. The duration of treatment is determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: Usually administer 400 mg of this medicine once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by clinical and mycological response, but treatment should usually continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as bone marrow transplant patients with severe or prolonged neutropenia. In these patients, administer 400 mg starting 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). Regrowth of new fingernails usually takes 3-6 months and toenails usually takes 6-12 months; growth rates may vary among individuals and by age. In some cases, fingernails or toenails may remain damaged after successful long-term treatment. For skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on the course. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Elderly patients If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval increased. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dosage adjustment is required for a single dose. If multiple doses are required, administer the usual dose only on the first day and adjust the dose from the next day as follows. Creatinine clearance (mL/min) Recommended dose > 50 100 % of the usual dose ≤50 (not on dialysis) 50% of the usual dose Patients on hemodialysis 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days without dialysis, administer a reduced dose according to creatinine clearance.

This medication should not be used in certain patients. It should not be taken by those allergic to this drug or other azole medications, or to any excipients contained in this drug. Women who are pregnant or may become pregnant and women who are breastfeeding should not take this medication. Also, there are specific drugs that can cause serious side effects when taken together with this medication, so it should not be used in combination with those drugs. Patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. There are patients who need to be cautious when taking this medication. Patients with a history of allergies or those with kidney or liver problems should use it more carefully. Patients with heart disease or electrolyte abnormalities that pose a risk of arrhythmias also need to exercise caution. Additionally, this drug may affect the metabolism of various medications, so dose adjustment and patient monitoring are required when used in combination with specific drugs. This medication is generally well tolerated, but rare adverse effects may occur in the blood, liver, and kidneys. Headaches, dyspepsia, rash, and liver function abnormalities have been reported, and in severe cases, there is a risk of hepatotoxicity or cardiac arrhythmias. If these symptoms occur, medical consultation should be sought immediately. Taking this drug during pregnancy may increase the risk of congenital malformations or miscarriage in the fetus, so it should not be used during pregnancy. Women of childbearing age should use effective contraception during the period of taking this drug and for one month after the last dose. Women who are breastfeeding should also avoid taking this drug as it is excreted in breast milk. The safety of this drug in children, especially infants under 6 months old, has not been sufficiently established and should only be used if necessary. This drug may sometimes cause dizziness or seizures, so caution is needed when driving or operating machinery. In case of overdose, hallucinations or abnormal behaviors may occur, and gastric lavage or supportive care may be necessary if required. This drug is primarily excreted in urine, so in cases of overdose, the drug concentration can be reduced through hemodialysis.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, sensory disturbance, taste disturbance, tremors, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, abdominal distension, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocellular necrosis, hepatitis, hepatocyte damage, rash, itching, hives, increased sweating, drug eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, alopecia, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, paranoid behavior

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, it is best stored at a cool room temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness.

Appearance

Capsule filled with white powder, upper part dark blue, lower part light blue

Package unit

30 capsules/bottle, 100 capsules/bottle